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Skye Bioscience (SKYE)
NASDAQ:SKYE
US Market

Skye Bioscience (SKYE) AI Stock Analysis

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SKYE

Skye Bioscience

(NASDAQ:SKYE)

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Neutral 49 (OpenAI - 5.2)
Rating:49Neutral
Price Target:
$0.93
▲(6.32% Upside)
The score is held back primarily by weak financial performance (pre-revenue losses and high/volatile cash burn implying financing risk) and bearish technicals (price below key moving averages with negative MACD). Earnings-call and corporate-event catalysts are a relative offset due to promising clinical combination results and improved delivery strategy, but they do not fully counterbalance the near-term funding and downtrend risks.
Positive Factors
Clinical Efficacy & Durability
Robust, durable weight‑loss signals from the nimacimab+semaglutide combo create a sustainable clinical differentiator in obesity therapeutics. Durable maintenance and favorable safety can improve reimbursement, support larger Phase 2b/3 design choices, and strengthen long‑term commercial positioning versus GLP‑1 monotherapy.
Low Leverage & Restored Equity
Extremely low debt and a return to positive equity reduce solvency risk and preserve financing optionality. This structural balance‑sheet strength lowers fixed obligations, making it easier to fund development through equity or partnerships without high interest burdens, improving long‑term resilience.
Strategic Delivery Collaboration
Partnering with Halozyme on ENHANZE addresses a structural commercialization hurdle — convenient subcutaneous delivery. If successful, proprietary delivery reduces patient friction, supports broader adoption, and de‑risks scale‑up by outsourcing core delivery tech and supply, improving long‑term market access prospects.
Negative Factors
Very High Cash Burn & Negative Cash Flow
Persistent, extreme negative cash flow is a durable structural risk: it forces repeated capital raises, dilutes shareholders, and can delay development if markets tighten. Ongoing large outflows undermine long‑term planning and increase the probability of financing terms that constrain strategic flexibility.
Widening Losses & Rising R&D Spend
Accelerating losses driven by higher R&D increase the burn rate before commercialization. This raises development financing needs and execution risk, and slows margin stabilization prospects. Higher spend without clear monotherapy efficacy increases the chance of costly additional studies or dose‑optimization programs.
Small Trial Sizes & Enrollment Constraints
Small extension cohorts limit statistical certainty and regulatory confidence, increasing the need for larger, costlier trials and prolonging timelines. For a small biotech with limited internal resources, underpowered studies create execution risk, potential delays in pivotal design and higher overall program cost.

Skye Bioscience (SKYE) vs. SPDR S&P 500 ETF (SPY)

Skye Bioscience Business Overview & Revenue Model

Company DescriptionSkye Bioscience, Inc., a biopharmaceutical company, discovers, develops, and commercializes cannabinoid-based molecules for the treatment of infectious diseases. The company's lead product candidate is SBI-100, which is in Phase I trials for the treatment of glaucoma and ocular hypertension. It is also developing SBI-200 that is in preclinical trials to treat and manage various eye diseases, including uveitis, dry eye syndrome, macular degeneration and diabetic retinopathy. The company was formerly known as Emerald Bioscience, Inc. and changed its name to Skye Bioscience, Inc. in January 2021. Skye Bioscience, Inc. was founded in 2012 and is headquartered in San Diego, California.
How the Company Makes MoneySkye Bioscience generates revenue through the development and eventual commercialization of its pharmaceutical products, which are primarily aimed at treating ocular diseases. The company's revenue model is built on the successful advancement of its drug candidates through clinical trials, regulatory approvals, and subsequent market entry. Key revenue streams include potential milestone payments and royalties from partnerships with larger pharmaceutical companies, as well as direct sales of approved products. Strategic collaborations and licensing agreements also play a crucial role in funding research and development activities, which are critical to advancing the company's drug pipeline. However, as of the current data, Skye Bioscience may still be in the pre-revenue stage, focusing on research and development efforts to bring its drug candidates to market.

Skye Bioscience Earnings Call Summary

Earnings Call Date:Nov 10, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 19, 2026
Earnings Call Sentiment Neutral
The earnings call presented a mixed picture with strong financial health and promising Phase 2a study results highlighting the potential of Nimazumab in combination with semaglutide. However, increased R&D expenses, a larger net loss, concerns about monotherapy efficacy, and limited study enrollment were notable challenges.
Q3-2025 Updates
Positive Updates
Strong Financial Position
Skye Bioscience ended the third quarter with cash and cash equivalents totaling $35.3 million, which is expected to fund operations and key clinical milestones into 2027.
Successful Phase 2a Study Results
The Phase 2a CBEYOND study showed synergistic efficacy with Nimazumab plus semaglutide, achieving approximately 3% additional weight loss at 26 weeks with a p-value of 0.0372, nearly a 30% improvement.
Positive Safety Profile
Nimazumab demonstrated a positive safety signal with no neuropsychiatric signals or additive GI burden.
Durability of Weight Loss
In a 12-week post-treatment follow-up, Nimazumab plus semaglutide showed significantly less weight regain (18% vs. 50% in semaglutide alone), with a p-value of 0.006.
Encouraging KOL Feedback
Key opinion leaders have responded positively to the combination data, emphasizing the potential for dosing holidays without significant weight regain.
Negative Updates
Increased R&D Expenses
R&D expenses for Q3 2025 increased to $9.4 million from $4.9 million in Q3 2024, primarily due to contract manufacturing and clinical trial costs.
Net Loss Increase
Net loss for Q3 2025 was $12.8 million compared to $3.9 million in Q3 2024.
Monotherapy Efficacy Concerns
The Phase 2a study indicated that patients were underdosed at 200 mg, and higher doses are needed to achieve expected efficacy in monotherapy.
Limited Patient Enrollment in Extension Study
Concerns were raised about the ability to draw statistically significant insights from the 43 patients enrolled in the 26-week extension study.
Company Guidance
In the Skye Bioscience, Inc. third-quarter 2025 earnings call, the company provided detailed guidance on its financial and clinical development milestones. Key financial highlights included ending the quarter with $35.3 million in cash and equivalents, with expectations to fund operations into 2027. R&D expenses increased to $9.4 million from $4.9 million in the previous year due to ongoing clinical trials, including those for Nolasimab and Nimazumab. Notably, the company reported a net loss of $12.8 million, attributed partly to non-cash share-based compensation expenses. Clinical updates focused on the promising results from the Phase 2a CBEYOND study, showing a 3% additional weight loss with Nimazumab plus semaglutide compared to semaglutide alone, with a significant p-value of 0.0372. The study also demonstrated improvements in lean to fat mass ratio and reduced waist circumference, with retention strong in the extension study. The company is advancing Nimazumab's dose concentration strategy and plans to evaluate higher doses in future studies, keeping scalability and patient convenience in focus.

Skye Bioscience Financial Statement Overview

Summary
Overall financial profile is weak: the company is pre-revenue with widening losses (TTM net income -$51.2M vs. -$26.6M in 2024) and persistently negative cash generation, including extremely large TTM operating/free cash outflows in the dataset that heighten financing/dilution risk. The balance sheet is a relative positive with very low leverage (debt-to-equity ~0.01) and restored positive equity versus prior negative-equity years.
Income Statement
12
Very Negative
Financials reflect a pre-revenue biotech profile with $0 revenue across all reported periods, so profitability is entirely driven by operating spend. Losses have widened versus 2024 (Net income: -$51.2M in TTM (Trailing-Twelve-Months) vs. -$26.6M in 2024), indicating accelerating burn rather than operating leverage. While this can be normal for development-stage biotech, it keeps near-term earnings quality and margin stability weak.
Balance Sheet
58
Neutral
Leverage is very low in the latest periods (TTM (Trailing-Twelve-Months) debt-to-equity ~0.01; 2024 ~0.01), which reduces solvency risk. Equity is positive and sizable in TTM (Trailing-Twelve-Months) and 2024, a notable improvement versus 2022–2023 when equity was negative. The main weakness is continuing large losses, which are eroding returns on equity (negative in TTM (Trailing-Twelve-Months) and 2024) and could pressure the capital base if funding is not replenished.
Cash Flow
15
Very Negative
Cash generation is materially negative, consistent with a development-stage company, but the latest TTM (Trailing-Twelve-Months) operating and free cash flow figures are extremely large outflows (operating cash flow about -$9.2B; free cash flow about -$9.2B), dwarfing reported net losses and suggesting a highly volatile cash-flow profile in the dataset. Even in prior annual periods, operating and free cash flow remained persistently negative, and 2024 free cash flow deteriorated sharply versus 2023. Overall, cash burn is a clear risk and likely necessitates ongoing external financing.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit0.000.000.000.000.00-1.87K
EBITDA-50.55M-25.29M-36.62M-18.70M-7.72M-5.85M
Net Income-51.23M-26.57M-37.64M-19.48M-8.52M-6.56M
Balance Sheet
Total Assets41.32M72.76M11.94M9.11M9.86M2.67M
Cash, Cash Equivalents and Short-Term Investments35.31M68.42M1.26M1.24M8.98M2.47M
Total Debt321.85K455.59K4.62M1.98M2.14M1.50M
Total Liabilities8.49M4.61M14.07M12.12M3.99M2.22M
Stockholders Equity32.84M68.15M-2.13M-3.01M5.86M450.79K
Cash Flow
Free Cash Flow-9.22B-26.84M-13.96M-12.77M-6.57M-6.06M
Operating Cash Flow-9.22B-25.24M-13.95M-12.74M-6.47M-6.05M
Investing Cash Flow-12.81B-245.62K6.60M5.21M-90.87K-7.23K
Financing Cash Flow23.78K83.56M16.44M-208.79K13.08M6.70M

Skye Bioscience Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.87
Price Trends
50DMA
1.03
Negative
100DMA
1.67
Negative
200DMA
2.34
Negative
Market Momentum
MACD
-0.03
Positive
RSI
40.54
Neutral
STOCH
8.56
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SKYE, the sentiment is Negative. The current price of 0.87 is below the 20-day moving average (MA) of 0.99, below the 50-day MA of 1.03, and below the 200-day MA of 2.34, indicating a bearish trend. The MACD of -0.03 indicates Positive momentum. The RSI at 40.54 is Neutral, neither overbought nor oversold. The STOCH value of 8.56 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for SKYE.

Skye Bioscience Risk Analysis

Skye Bioscience disclosed 51 risk factors in its most recent earnings report. Skye Bioscience reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 3 New Risks
1.
We may face risks related to the wind-down of EHT's operations. Q4, 2022
2.
Government authorities extensively regulate our activities. Q4, 2022
3.
Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product candidates and may affect the prices we may set. Q4, 2022

Skye Bioscience Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$40.41M-0.66-155.77%19.05%2.01%
50
Neutral
$32.99M-1.46-104.58%1.18%
49
Neutral
$27.89M-0.62-94.31%-53.18%
47
Neutral
$32.59M-0.14-66.96%71.83%
45
Neutral
$36.19M-1.05-133.09%11.11%20.65%
41
Neutral
$29.40M-0.3686.28%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
SKYE
Skye Bioscience
0.80
-2.18
-73.19%
ATNM
Actinium Pharmaceuticals
1.16
0.01
0.87%
OTLK
Outlook Therapeutics
0.39
-1.34
-77.46%
BTAI
Bioxcel Therapeutics
1.37
-1.61
-54.03%
INMB
Inmune Bio
1.42
-8.38
-85.51%
LTRN
Lantern Pharma
2.56
-2.74
-51.70%

Skye Bioscience Corporate Events

Business Operations and StrategyProduct-Related Announcements
Skye Bioscience Reports Promising Phase 2a Obesity Data
Positive
Feb 2, 2026

On February 2, 2026, Skye Bioscience reported interim 52‑week data from the combination arm of its Phase 2a CBeyond extension study in obesity, showing that patients receiving nimacimab plus semaglutide achieved a mean weight loss of 22.3% with no plateau observed, versus 19.7% with semaglutide plus placebo, and that the combination maintained a favorable safety and tolerability profile with no serious adverse events or adverse events of special interest. The company also highlighted that, during a 13‑week off‑therapy period, patients previously treated with the nimacimab–semaglutide combination regained only 17.8% of their lost weight compared with 37.3% for semaglutide alone, suggesting a durability advantage that could strengthen Skye’s competitive positioning in the crowded obesity market as it advances nimacimab toward larger Phase 2b studies and continues to manage its cash runway, which it expects to support operations and key clinical milestones into the fourth quarter of 2026.

The most recent analyst rating on (SKYE) stock is a Hold with a $0.94 price target. To see the full list of analyst forecasts on Skye Bioscience stock, see the SKYE Stock Forecast page.

Business Operations and StrategyProduct-Related Announcements
Skye Bioscience Collaborates with Halozyme on Nimacimab Delivery
Positive
Dec 23, 2025

On December 18, 2025, Skye Bioscience, Inc. entered into a non-exclusive collaboration and license agreement with Halozyme, Inc. to use Halozyme’s ENHANZE drug delivery technology to develop a subcutaneous formulation of Skye’s antibody nimacimab, with Halozyme serving as the exclusive supplier of clinical and commercial rHuPH20 bulk drug product. The deal includes milestone payments tied to development, commercialization, and net sales thresholds, along with mid-single-digit royalties on global sales, reflecting a standard biotech licensing structure that could enhance Skye’s ability to deliver nimacimab more conveniently to patients and potentially strengthen its competitive position if the product advances successfully.

The most recent analyst rating on (SKYE) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Skye Bioscience stock, see the SKYE Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Feb 03, 2026